Samsung Bioepis has won a patent invalidation suit against Roche’s Herceptin in Korea.

Samsung Bioepis’ Samfenet (SB3), known as Ontruzant outside of Korea, is a biosimilar of Roche’s blockbuster breast cancer treatment Herceptin (trastuzumab). Samsung Bioepis received marketing approval for Samfenet from South Korea’s Ministry of Food and Drug Safety (MFDS) in November 2017 [1], and it has been distributed domestically by Daewoong Pharmaceutical since March 2018 [2].

In July 2017, Samsung Bioepis requested the invalidation of Roche’s patent for ‘Protein Purification by Ion-Exchange Chromatography’ on the basis that it lacks patentability. In March 2019, Korea’s Intellectual Property Trial and Appeal Board (IPTAB) accepted Samsung Bioepis’ claim and invalidated the patent, which was due to expire in May 2019. The IPTAB’s decision will prevent Roche filing any injunction against the sale of Samfenet in Korea, and Samsung Bioepis and Daewoong Pharmaceutical said they would use this decision as an opportunity to expand Samfenet’s market share in Korea. To date, sales for Samfenet have been slow; according to IQVIA, total sales of Samfenet only reached US$5.5 million in the local market in 2018.

Samfenet is not the first trastuzumab biosimilar on the Korean market. In September 2017, Celltrion launched its trastuzumab biosimilar Herzuma after gaining MFDS approval in January 2014 [3]. In 2015, Celltrion invalidated Herceptin’s patent for a ‘monoclonal or multiclonal antibody freeze-drying substance’.

The patent recently nullified by Samsung Bioepis was the last remaining patent in Korea registered for Herceptin.

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